Z-0575-2020Class II

Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward...

Name: Z-0575-2020 Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward...
Creator: Abbott GmBH & Co. KG
Published: 2019-10-23
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-10-23 / Terminated

FDA source

Abbott GmBH & Co. KG began a recall of Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada on 2019-10-23. FDA classified it as Class II and gives the reason as "Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in the potential for incorrect results. Abbott was made aware of this...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0575-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-23
Posted: 2019-11-26
Terminated: 2021-05-14
Recalling firm: Abbott Medical
Product: Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
Product code: KHS Enzymatic, Carbon-Dioxide
Reason for recall: Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in the potential for incorrect results. Abbott was made aware of this issue from customer complaints. Internal testing demonstrated that the amount of CO2 absorbed is higher with increased reagent carousel rotation and when the volume of reagent in the cartridge is reduced. This phenomenon can be detected as a shift in QC. The shift is predictive in both direction and magnitude of the potential impact to patient results.
FDA root cause: Under Investigation by firm
Action: On 10/23/19, a Product Recall letter was issued to all worldwide Alinity c Carbon Dioxide Reagent customers who received the in-date lots. US customers were sent this information via FedEx priority overnight. Customers are asked to immediately discontinue use and destroy product from LN 07P7230 lot 54449UQ03. For LN 07P7220 lot 54454UQ03, the product may continue to be used but 2 levels of CO2 controls must be run every hour until the new material is received. If you or any of the health care providers you serve have any questions regarding this information, US Customers can contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week). Customers outside the US , please contact your local area Customer Service.
Quantity in commerce: 105 kits (lot 54449UQ03) and 1215 kits (lot 54454UQ03)
Distribution: Worldwide and US Nationwide in the states of: AL, AR, CA, CO, FL, GA, ID, IL, LA, MA, MI, MN, MO, NC, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico Foreign: AUSTRALIA, BANGLADESH, BELGIUM, BOTSWANA, BRAZIL, CANADA, COLOMBIA, DENMARK, FRANCE, GREECE, Hong Kong, INDIA, ITALY, JAMAICA, LEBANON, MAURITIUS, NAMIBIA, NETHERLANDS, NEW ZEALAND, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, UAE, and UNITED KINGDOM
Product codes and lots: REF # 07P7220 Lot # 54454UQ03 and REF # 07P7230 Lot # 54449UQ03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0575-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0575-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25

Product code KHS

K060295Class IICarbon DioxideAbbott Laboratories / cleared 2006-05-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)